Clinical trial • Phase III • Oncology

SAVOLITINIB for Non-small cell lung cancer

Phase III trial of SAVOLITINIB for Non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
26-07-2024

Trial design

Randomised, open-label, platinum-based doublet chemotherapy: pemetrexed plus cisplatin or carboplatin (pemetrexed iv; product entries indicate pemetrexed dosing unit mg/m2, max daily amount 500 mg/m2; cisplatin dosing unit mg/m2, max daily amount 75 mg/m2; carboplatin dosing unit mg, max daily amount 750 mg). comparator arm includes platinum-doublet chemotherapy followed by pemetrexed maintenance.-controlled Phase III trial in Belgium, Spain, Bulgaria and others.

Randomised
Yes
Open Label
Yes
Comparator
Platinum-based doublet chemotherapy: pemetrexed plus cisplatin or carboplatin (pemetrexed IV; product entries indicate pemetrexed dosing unit mg/m2, max daily amount 500 mg/m2; cisplatin dosing unit mg/m2, max daily amount 75 mg/m2; carboplatin dosing unit mg, max daily amount 750 mg). Comparator arm includes platinum-doublet chemotherapy followed by pemetrexed maintenance.
Biomarker Stratified
True, biomarker: MET (overexpression by IHC and/or amplification by FISH); EGFR mutation required (sensitising EGFR mutations).
Target Sample Size
324

Eligibility

Recruits 324 Vulnerable population selected; consent obtained from participant: 'Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.' No specific assent or parental consent procedures described in the available criteria..

Vulnerable Population
Vulnerable population selected; consent obtained from participant: 'Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.' No specific assent or parental consent procedures described in the available criteria.

Inclusion criteria

  • {"criterion_text":"- Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses."}
  • {"criterion_text":"- ECOG performance status of 0 or 1."}
  • {"criterion_text":"- Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted."}
  • {"criterion_text":"- Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy."}
  • {"criterion_text":"- Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M."}
  • {"criterion_text":"- Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy."}
  • {"criterion_text":"- Mandatory provision of FFPE tumour tissue."}
  • {"criterion_text":"- MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment."}
  • {"criterion_text":"- Measurable disease as defined by RECIST 1.1."}
  • {"criterion_text":"- Adequate haematological, liver, renal and cardiac functions, and coagulation parameters."}

Exclusion criteria

  • {"criterion_text":"- Squamous NSCLC, and small cell lung cancer."}
  • {"criterion_text":"- History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement."}
  • {"criterion_text":"- Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease."}
  • {"criterion_text":"- Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention."}
  • {"criterion_text":"- Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD."}
  • {"criterion_text":"- Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib."}
  • {"criterion_text":"- Prior or current treatment with savolitinib or another MET inhibitors."}
  • {"criterion_text":"- Spinal cord compression or brain metastases, unless asymptomatic and are stable."}
  • {"criterion_text":"- History or active leptomeningeal carcinomatosis."}
  • {"criterion_text":"- Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 and prior platinum-therapy related Grade 2 neuropathies with the exception of alopecia and haemoglobin ≥ 9.0 g/dL."}
  • {"criterion_text":"- Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS as defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause in participants with centrally confirmed MET IHC+ and/or MET FISH+ status (FAS). The comparison will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy, or clinically progresses prior to RECIST 1.1 progression.","definition_or_measurement_approach":"PFS measured as time from randomisation until progression per RECIST 1.1 as assessed by independent blinded central review (BICR), or death from any cause, in participants with centrally confirmed MET IHC+ and/or MET FISH+ status (FAS)."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival defined as time from randomisation until the date of death due to any cause.","definition_or_measurement_approach":"Time from randomisation until date of death from any cause (OS)."}
  • {"endpoint_text":"- Progression-free survival defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause in centrally confirmed MET IHC+ population of FAS (FAS-IHC+).","definition_or_measurement_approach":"PFS measured by RECIST 1.1 as assessed by BICR or death, in centrally confirmed MET IHC+ population (FAS-IHC+)."}
  • {"endpoint_text":"- Overall survival defined as time from randomisation until the date of death due to any cause in FAS-IHC+.","definition_or_measurement_approach":"OS in the FAS-IHC+ population (time from randomisation to death from any cause)."}
  • {"endpoint_text":"- Progression-free survival defined as time from randomization until progression per RECIST 1.1 as assessed by investigator, or death due to any cause in centrally confirmed MET IHC+ population of FAS (FASIHC+).","definition_or_measurement_approach":"Investigator-assessed PFS by RECIST 1.1 or death in centrally confirmed MET IHC+ population (FAS-IHC+)."}
  • {"endpoint_text":"- A/ Objective response rate will be based on BOR defined as the proportion of participants who have BOR of a CR or PR, as determined by BICR per RECIST 1.1. B/ Duration of response defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR, or death in the absence of disease progression. C/Disease control rate defined as the proportion of participants who have BOR of a CR, PR, or stable disease [...]","definition_or_measurement_approach":"ORR based on best overall response (BOR) = proportion with CR or PR by BICR per RECIST 1.1; DoR = time from first documented response to documented progression by RECIST 1.1 by BICR or death; DCR = proportion with CR, PR or SD."}
  • {"endpoint_text":"- A/ TTD in pulmonary core symptoms (dyspnoea, cough, and chest pain) as measured by the questionnaire. B/TTD is defined as the time from randomisation until the date of deterioration.","definition_or_measurement_approach":"Time to deterioration (TTD) in pulmonary symptoms measured by patient questionnaire; defined as time from randomisation to date of deterioration."}
  • {"endpoint_text":"- Plasma concentrations of savolitinib and its metabolites in the PK Analysis Set.","definition_or_measurement_approach":"PK measurement of plasma concentrations of savolitinib and metabolites in PK Analysis Set."}
  • {"endpoint_text":"- Safety and tolerability will be evaluated in terms of AEs, SAEs, discontinuation rate due to AEs and deaths; clinical chemistry/haematology including LFTs; ECHOs/MUGAs, ECGs, ECOG performance status and vital signs in the Safety Analysis Set.","definition_or_measurement_approach":"Safety assessments: AEs/SAEs, discontinuations due to AEs, deaths, clinical labs including LFTs, ECHOs/MUGAs, ECGs, ECOG PS and vital signs, in Safety Analysis Set."}
  • {"endpoint_text":"- CNS PFS, defined as the time from randomisation until the date of CNS progression assessed per CNS modified RECIST v1.1 by BICR or death in the FAS population. • CNS ORR defined as the proportion of participants who have a BOR in the CNS by BICR assessment in the cFAS population. • CNS DoR defined as the time from the date of first documented response in the CNS until the date of objective CNS progression as assessed by BICR or death in the absence of disease progression in the cFAS population.","definition_or_measurement_approach":"CNS-specific endpoints: CNS PFS (time to CNS progression by CNS-modified RECIST v1.1 by BICR or death), CNS ORR (proportion with BOR in CNS by BICR), CNS DoR (time from first CNS response to CNS progression by BICR or death)."}

Recruitment

Registry Or Advocacy Recruitment
True, advocacy outreach materials referenced (no specific organisation or registry names provided in the available documents).
Digital Remote Recruitment
True, materials include study website content, video scripts and digital patient brochures in local languages to support online recruitment.
Planned Sample Size
324
Recruitment Window Months
49
Consent Approach
Participants must provide a signed and dated written informed consent form prior to any study-specific procedures: 'Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.' Participants must be ≥18 years (≥19 in South Korea). Consent documents and related materials (including optional genetic research and pregnancy/partner information) are available in multiple country-specific languages (examples in the dossier: English, French, Dutch, Spanish, Bulgarian, German, Italian, Polish, Greek).

Methods

  • Advocacy Outreach — engagement materials labelled 'Advocacy Outreach' provided as recruitment material (country-specific versions present).
  • Patient Brochure — printed/digital patient brochure materials prepared for potential participants (country/language-specific versions present).
  • Study Website — study website materials prepared (country/language-specific versions present).
  • Video Script — scripted recruitment videos (country/language-specific versions present).
  • Recruitment arrangements form — formal recruitment arrangements documents per country (K1 recruitment arrangements forms).

Geography

Total Number Of Sites
87
Total Number Of Participants
87

Belgium

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
26-07-2024
Processing Time Days
24
Number Of Sites
7
Number Of Participants
6

Sites

Site Name
Algemeen Ziekenhuis Delta
Department Name
Oncology
Contact Person Name
Ingel Demedts
Contact Person Email
ingel.demedts@azdelta.be
Site Name
CHU Helora
Department Name
Oncology
Contact Person Name
Stephane Holbrechts
Contact Person Email
stephane.holbrechts@hap.be
Site Name
Antwerp University Hospital
Department Name
Oncology
Contact Person Name
Jo Raskin
Contact Person Email
jo.raskin@uza.be
Site Name
Vitaz
Department Name
Oncology
Contact Person Name
Koenraad Deschepper
Contact Person Email
koen.deschepper@vitaz.be
Site Name
Jessa Ziekenhuis
Department Name
Oncology
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be
Site Name
Institut Jules Bordet
Department Name
Oncology
Contact Person Name
Mariana Brandao
Contact Person Email
mariana.brandao@bordet.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology
Contact Person Name
Veerle Surmont
Contact Person Email
Veerle.surmont@uzgent.Be

Spain

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
29-07-2024
Processing Time Days
27
Number Of Sites
18
Number Of Participants
12

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Manuel Angel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Carlos Aguado de la Rosa
Site Name
Hospital Alvaro Cunqueiro
Department Name
Oncology
Contact Person Name
Martin Lázaro Quintela
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Noemi Reguart Aransay
Contact Person Email
NREGUART@clinic.cat
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Contact Person Name
Isidoro Carlos Barneto Aranda
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Contact Person Name
Maria Dolores Isla Casado
Contact Person Email
lola.isla@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Oscar Jose Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Universitario De Badajoz
Department Name
Oncology
Contact Person Name
Marta González Cordero
Site Name
Hospital Germans Trias I Pujol
Department Name
Oncology
Contact Person Name
Enric Carcereny Costa
Contact Person Email
ecarcereny@iconcologia.net
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
Maria Rosario García Campelo
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Contact Person Name
Laia Vila Martinez
Contact Person Email
lvila@tauli.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
David Vicente Baz
Contact Person Email
dvicentebaz@yahoo.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Manuel Angel Domine Gómez
Contact Person Email
mdomine@fjd.es
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Joaquim Bosch-Barrera
Contact Person Email
jbosch@iconcologia.net

Bulgaria

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
14-08-2024
Processing Time Days
43
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
First department of medical oncology
Contact Person Name
Nataliya Chilingirova

Germany

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
31-07-2024
Processing Time Days
29
Number Of Sites
12
Number Of Participants
12

Sites

Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Med. Klinik II, Onkologie
Contact Person Name
Jonas Kuon
Contact Person Email
Jonas.Kuon@slk-kliniken.de
Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
Lungenklinik Heckeshorn
Contact Person Name
Daniel Misch
Site Name
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
Contact Person Name
Rüdiger Liersch
Contact Person Email
liersch@onkologie-muenster.de
Site Name
Waldburg-Zeil Akutkliniken GmbH & Co. KG
Department Name
Fachkliniken Wangen Klinik für Pneumologie
Contact Person Name
Philipp Meyn
Contact Person Email
Philipp.meyn@wz-kliniken.de
Site Name
Asklepios Klinik Gauting GmbH
Department Name
Onkologie
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Lungentumorambulanz, Südring 9
Contact Person Name
Nikolaj Frost
Contact Person Email
nikolaj.frost@charite.de
Site Name
Muenchen Klinik gGmbH
Department Name
Klinik für Pneumologie und pneumologische Onkologie
Contact Person Name
Konrad Kokowski
Site Name
Goethe University Frankfurt
Department Name
Pneumology
Contact Person Name
Wolfgang Gleiber
Contact Person Email
Wolfgang.gleiber@kgu.de
Site Name
Lungenfachklinik Immenhausen
Department Name
Onkologische Ambulanz
Contact Person Name
Achim Rittmeyer
Site Name
Klinikum Chemnitz gGmbH
Department Name
Onkologie/Pneumologie
Contact Person Name
Stefan Hammerschmidt
Contact Person Email
S.Hammerschmidt@skc.de
Site Name
Asklepios Klinik Gauting GmbH (duplicate site listing in dataset?)
Site Name
Weitere deutsche Studienzentren (siehe Einreichungsunterlagen)

Austria

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
31-07-2024
Processing Time Days
29
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Universitatsklinik fuer Innere Medizin III der PMU
Contact Person Name
Teresa Magnes
Contact Person Email
t.magnes@salk.at

France

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
30-07-2024
Processing Time Days
28
Number Of Sites
18
Number Of Participants
18

Sites

Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Pneumologie
Contact Person Name
Isabelle Monnet
Contact Person Email
isabelle.monnet@chicreteil.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pneumologie
Contact Person Name
Celine Mascaux
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Institut de Cancerologie et Hematologie
Contact Person Name
Gilles Quere
Contact Person Email
gilles.quere@chu-brest.fr
Site Name
Institut Curie
Department Name
Oncologie Médicale
Contact Person Name
Catherine Daniel
Contact Person Email
catherine.daniel@curie.fr
Site Name
Hospital Foch
Department Name
Oncologie Médicale
Contact Person Name
Jaafar Bennouna
Contact Person Email
j.bennouna@hopital-foch.com
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Pneumologie
Contact Person Name
Herve Lena
Contact Person Email
herve.lena@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Oncologie Médicale
Contact Person Name
Charlotte Domblides
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncologie Médicale
Contact Person Name
Elvire Pons-Tostivint
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Pneumologie
Contact Person Name
Gregoire Justeau
Contact Person Email
gregoire.justeau@chu-anger.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie Médicale
Contact Person Name
Boris Duchemann
Contact Person Email
lise.matton@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
Contact Person Name
Pascale Tomasini
Contact Person Email
pascale.tomasini@ap-hm.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Pneumologie
Contact Person Name
Florian Guisier
Contact Person Email
florian.guisier@chu-rouen.fr
Site Name
Centre Hospitalier De Saint-Quentin
Department Name
Pneumologie
Contact Person Name
Charles Dayen
Contact Person Email
c.dayen@ch-stquentin.fr
Site Name
Centre Hospitalier De Poitiers
Department Name
Oncologie Médicale
Contact Person Name
Corinne Lamour
Contact Person Email
corinne.lamour@chu-poitiers.fr
Site Name
Centre Georges Francois Leclerc
Department Name
Oncologie Médicale
Contact Person Name
Aurelie Lagrange
Contact Person Email
alagrange@cgfl.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest (duplicate listing handled above)
Site Name
Centre Hospitalier Universitaire De Saint-Quentin (other French centres listed in dossier)

Greece

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
29-07-2024
Processing Time Days
27
Number Of Sites
9
Number Of Participants
7

Sites

Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Clinic
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
Department of Medical Oncology
Contact Person Name
Athanasios Kotsakis
Contact Person Email
kotsakisthan@gmail.com
Site Name
University General Hospital Attikon
Department Name
2nd Propaedeutic Internal Medicine Clinic & Research Unit- Oncology Unit
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Bioclinic S.A.
Department Name
Oncology Unit
Contact Person Name
Ioannis Boukovinas
Contact Person Email
iboukovinas@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Propaedeutic Internal Medicine Clinic & Research Unit- Oncology Unit
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
General University Hospital Of Patras
Department Name
Oncology Department of Internal Medicine Clinic
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
Theageneio Cancer Hospital
Department Name
Pulmonary- Oncology Department
Contact Person Name
Theodora Tsiouda
Contact Person Email
doratsiouda@yahoo.gr
Site Name
University General Hospital Of Heraklion
Department Name
Department of Medical Oncology
Contact Person Name
Dimitrios Mavroudis
Contact Person Email
mavroudis@uoc.gr
Site Name
Additional Greek centres (see application documents)

Poland

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
04-08-2024
Processing Time Days
33
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Onkologii z pododdziałem chemioterapii
Contact Person Name
Jarosław Kołb Sielecki
Contact Person Email
j.kolbsielecki@gmail.com
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
II Klinika Chorób Płuc, Raka Płuca i Chorób Wewnętrznych
Contact Person Name
Robert Mróz
Contact Person Email
robmmroz@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
05-08-2024
Processing Time Days
34
Number Of Sites
18
Number Of Participants
18

Sites

Site Name
San Camillo Forlanini Hospital
Department Name
Oncology
Contact Person Name
Serena Ricciardi
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
Oncology
Contact Person Name
Mario Scartozzi
Contact Person Email
marioscartozzi@unica.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Contact Person Name
Laura Bonanno
Contact Person Email
laura.bonanno@iov.veneto.it
Site Name
AORN San Giuseppe Moscati Avellino
Department Name
Oncology
Contact Person Name
Cesare Gridelli
Contact Person Email
cegridelli@aosgmoscati.av.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncology
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncology
Contact Person Name
Alessandra Bearz
Contact Person Email
alessandra.bearz@cro.it
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Oncology
Contact Person Name
Floriana Morgillo
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncology
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Oncology
Contact Person Name
Federica Bertolini
Contact Person Email
bertolini.federica@aou.mo.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncology
Contact Person Name
Antonio Passaro
Contact Person Email
antonio.passaro@ieo.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Oncology
Contact Person Name
Giulio Metro
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncology
Contact Person Name
Claudia Proto
Site Name
Azienda Unita Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Oncology
Contact Person Name
Adolfo Favaretto
Site Name
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
Department Name
Oncology
Contact Person Name
Antonio Santo
Contact Person Email
asanto@ospedalepederzoli.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
Oncology
Contact Person Name
Hector Soto Parra
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncology
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.gov.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
Oncology
Contact Person Name
Marcello Tiseo
Contact Person Email
mtiseo@ao.pr.it

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Fortrea Inc.
Responsibilities
Listed sponsor duties codes including DMC for blinded data and other operational/sponsor duties (see sponsorDuties codes in dossier); contact submissions@fortrea.com

Third parties

  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,15 (DMC for blinded data),2,4,5,6,7,8,9; contact submissions@fortrea.com","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Savolitinib
Active Substance
SAVOLITINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus:1 (not authorised/clinical product)
Maximum Dose
600 mg (maxDailyDoseAmount as listed)
Investigational Product Name
Osimertinib (TAGRISSO 40 mg / 80 mg)
Active Substance
OSIMERTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Marketing authorisation present for TAGRISSO (prodAuthStatus:2; marketingAuthorisation numbers present in product dictionary)
Maximum Dose
40 mg (TAGRISSO 40 mg entry maxDailyDoseAmount 40 mg) and 80 mg (TAGRISSO 80 mg entry maxDailyDoseAmount 80 mg)
Investigational Product Name
Pemetrexed (comparators/maintenance)
Active Substance
PEMETREXED
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Marketing authorised for listed pemetrexed products (prodAuthStatus:2 in product entries)
Maximum Dose
500 mg/m2 (maxDailyDoseAmount as listed for pemetrexed entries)
Investigational Product Name
Cisplatin (comparators)
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Marketing authorised for listed cisplatin products (prodAuthStatus:2)
Maximum Dose
75 mg/m2 (maxDailyDoseAmount as listed)
Investigational Product Name
Carboplatin (comparators)
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Marketing authorised for listed carboplatin products (prodAuthStatus:2)
Maximum Dose
750 mg (maxDailyDoseAmount as listed)
Combination Treatment
Yes

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